An Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies
Completed
Conditions studied: Peripheral Arterial Disease
In brief
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).
Key facts
- Study ID
- NCT02921542
- Run by
- Spectranetics Corporation
- People needed
- 57
- Starts
- 2016-08-15
- Expected to finish
- 2019-05-01
- Last updated by the study team
- 2019-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient age at least 18 years.
- Patient has been informed of the nature of the study, agrees to participate and has signed an approved consent form.
- Rutherford category 1, 2, 3, or 4
- Subject Patient presents with clinical evidence of PAD requiring endovascular intervention.
- Target lesion access must use the femoral approach that will accommodate at least a 7Fr sheath.
- Angiographic evidence of significant restenosis (≥ 50% by visual estimate).
You may not qualify if…
- Inability to obtain informed consent.
- Life expectancy < 12 months.
- Pregnancy, suspected pregnancy, or breastfeeding during study period. (Patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment.
- Any evidence of hemodynamic instability prior to procedure/randomization
- Coagulopathy or clotting disorders.
- Present or suspected systemic infection or osteomyelitis affecting target limb.
- Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytic, etc).
Where it is running
- Rex Hospital — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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